Gain market access in Brazil with ANVISA approval

Electro-medical device product certification in Brazil

Brazil is one of the most interesting new export markets for medical device manufacturers in North America, Europe and Asia. As one the BRIC economies (Brazil, Russia, India and China) it represents significant market growth opportunities.

In surveys over the last three years, Brazil has been consistently identified by medical device manufacturers as a top new market to consider for their medical devices.

Brazilian Medical Device Regulations

All medical devices in Brazil are regulated by the Brazilian Health Surveillance Agency (ANVISA). ANVISA requires that all devices must complete a device registration process. Non-Brazilian manufacturers need a local Brazilian Registration Holder (BRH) based in Brazil to submit technical files to ANVISA.

The Brazilian Regulation uses a risk-based classification system to classify devices into one of four groups: Class I (low risk) to Class IV (high risk). In addition, all of your manufacturing locations must comply with Brazilian GMP requirements (RESOLUÇÃO DA DIRETORIA COLEGIADA - RDC N°16, Brazilian regulations similar to ISO 13485).

Brazil and the Medical Device Single Audit Program (MDSAP)

ANVISA utilizes the outcomes of the program, including the reports, to constitute an important input on ANVISA’s pre-market and post-market assessment procedures. Providing, when applicable, key information that are expected to support regulatory technical evaluation on these issues.

MDSAP audits are conducted by recognized Auditing Organizations (AOs); BSI is a recognized AO and participated in the Program's pilot phase.

Electro-Medical Devices IEC 60601 and INMETRO

IEC 60601 is the international standard for safety of electro-medical devices. Electro-medical devices entering Brazil require a mandatory INMETRO* IEC 60601 product certification, this must be completed before applying for ANVISA registration. BSI Brazil is accredited by INMETRO to issue IEC 60601 Product Certification.

All electro-medical manufacturers must have a local representative that will apply for product certification. Medical devices must be tested to IEC 60601 and the relevant parts of the standard, manufacturers will audited by the INMETRO Product Certification Body or their approved agent, product certification is issued for up to five years.

* INMETRO is the national accreditation body for testing, certification and system assessment.